Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADL5945 · 2 trials · 2 indications
An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week). |
| ADL5945 0.25 mg | EXPERIMENTAL | During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. |
| ADL5945 0.1 mg | EXPERIMENTAL | During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-milligrams (mg) ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | - |
| ADL5945 0.25 mg | DRUG | - |
| ADL5945 0.1 mg | DRUG | - |
Key Inclusion Criteria * be a man or woman aged 18 to 75 years, inclusive, at the time of screening * have a body weight ≥45 kilograms (kg) and a body mass index (BMI) ≤40 kilograms per square meter (kg/m\^2) * be taking a stable daily dose of opioids of ≥30-milligrams (mg) morphine-equivalent tota...
ADL5945 is an investigational small molecule being studied for the treatment of constipation, including opioid induced constipation in adults taking opioid therapy for chronic noncancer pain. It is a Phase 2 candidate and is not yet approved for any indication.
ADL5945 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company has sponsored the clinical program evaluating the drug in patients with opioid induced constipation.
ADL5945 is in Phase 2 clinical development. It has completed Phase 2 trials in opioid induced constipation and has not advanced to Phase 3. It remains an investigational drug and is not approved for commercial use.
ADL5945 has been evaluated in two completed Phase 2 trials: NCT01275755, which enrolled 81 patients, and NCT01207427, which enrolled 131 patients. Both studied once daily dosing for opioid induced constipation in adults on opioid therapy for chronic noncancer pain.
The ADL5945 trials were randomized, double blind, and placebo controlled. They enrolled adults aged 18 years and older of all sexes, and excluded healthy volunteers. The studies evaluated once daily dosing for opioid induced constipation in patients receiving opioid therapy for chronic noncancer pain.